T-ICD vs S-ICD Shocks: Myocardial Injuries

Myocardial Injuries and Hemodynamic Stress Biomarkers: a Comparison Between Transvenous and Subcutaneous ICD Shock

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03458065

Acronym

MYSTIC

Enrollment

100

Registered

2018-03-08

Start date

2018-04-01

Completion date

2019-03-01

Last updated

2018-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ICD Shock Myocardial Injuries

Brief summary

Implantable cardioverter defibrillator (ICD) shocks are associated with a subsequent increased risk of death, and an elevation of cardiac enzymes has been measured after defibrillation testing (DFT). The aim of our study was to investigate the association between S-ICD vs T-ICD shocks and acute cardiac damage in humans, as evaluated by means of sensitive and highly specific circulating biomarkers

Interventions

DEVICEICD

Implantable Cardioverter Defibrillator

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

patients who met the criteria for ICD implantation according to the current guidelines

Exclusion criteria

Design outcomes

Primary

Measure	Time frame	Description
myocardial micro-damage	6 months	degree of myocardial micro-damage, assessed by calculating the variation in the serum levels of high-sensitivity cardiac troponin I (hs-CTnI) and creatine kinase-MB mass concentration (CK-MB mass), measured before and after an S-ICD shock delivered during intraoperative DFT

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026